Request for Project Proposals - Pharmacogenomics (PGx) Testing for Military Readiness Pilot

The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary announcement for the MTEC-25-07-Pharmacogenomics Request for Project Proposals (RPP) focused on establishing a pilot program to demonstrate the enhanced use of pharmacogenomics (PGx) in the Military Health System (MHS) to aid in the treatment for specific medical conditions and improve healthcare delivery and outcomes. As stated at the end of this announcement, the full RPP is posted to the MTEC website (mtec-sc.org); this notice is intended only to notify interested parties of the available solicitation. Background: DHA Research & Engineering Directorate is requesting proposals for a PGx pilot program to aid and improve military readiness and clinical care for military personnel in response to the FY24 DoD Appropriations Act. The pilot program will develop and demonstrate the standards and processes that will result in MHS protocols for routine PGx testing in applicable military cohorts and report PGx testing results that can provide actionable information to MHS providers for medical treatment of the Active-Duty population. The pilot will leverage the Electronic Health Record (EHR) patient information and patient outcomes to determine and report optimal healthcare delivery. Results from this program will demonstrate the feasibility of utilizing PGx as an impactful and cost-effective solution to improve the personalization, safety, and efficacy of medication for Active-Duty service members (ADSM). The intent of the PGx pilot program is to demonstrate the impact PGx can have on the ADSMs by preventing adverse drug reactions, optimizing drug dosing, and reducing the use of non-effective medications, as well as demonstrating the cost benefit, quality, and outcomes of treatment. The PGx pilot program scope will include development of appropriate PGx processes (e.g. enrollment) relevant to military populations at DoD site(s), tracking outcomes after medical treatment, and performing analyses to determine treatment efficacy based on PGx testing. Technical Objective: Proposed solutions are expected to include (but are not limited to) the following characteristics and activities: Collaborate with Military Treatment Facilities to maximize the use of precision medicine in clinical care for ADSMs. Establish a process for the integration of PGx into clinical care. This will include development of an Application Programming Interface within the MHS EHR within the DoD secured server under strict data and national security requirements in accordance with National Institute of Standards and Technology 8582 and DFARS 239.7602-2(a). Identify, establish, and execute programmatic tasks of the pilot program. These may include, but are not limited to: Document pilot processes for Clinical PGx and tele-PGx platform within the MHS through the EHR, for PGx consultation, education, and fluency across the MHS community. Conduct data collection, and data analysis, to include the measurement of effectiveness of PGx processes. Measure treatment efficacy with respect to: reductions in adverse drug reactions and use of non-effective medications; treatment outcomes; informing long-term medication management for improvements in clinical health conditions; and cost related to testing, treatment, and ADSM return to duty Ensure the use of all appropriate Clinical Pharmacogenetics Implementation Consortium guidelines, where appropriate. Develop progress and final reports with recommendations based on data analysis Requirements for the Proposed Team: The following are the anticipated requirements to consider when forming a team and are considered necessary to ensure the successful development of the project. This pilot program would require the awardee team to include clinical pharmacists trained in PGx, especially those with practical experience in implementing PGx with therapeutic conditions in one or more of the following medical conditions prioritized in the MHS: behavioral health, pain management, cardiology, infectious diseases, gastrointestinal disorders, and sleep disorders, etc. Other clinical conditions may be proposed as appropriate. Must satisfy requirements to receive access to government furnished equipment (i.e., computer) and obtain a government common access card - to be determined by DHA data access approval authority. This is anticipated in order to access electronic health records (de-identified) to determine the health outcomes from pharmacogenomics testing. The vendor/contractor MUST be willing and able to partner with Defense Health Agency clinical subject matter experts (to be specified post award) to ensure timely approval and access to DoD populations and medical data, to fulfill data security requirements, and maximize translation of findings to the MHS. Potential Follow-on Tasks: Under awards resulting from this RPP, there is the potential for award of one or more non-competitive follow-on tasks based on the success of the project (subject to change depending upon Government review of completed work and successful progression of milestones). Potential follow-on work may be awarded based on the advancement in prototype maturity during the initial PoP. Follow-on work may include, but are not limited to, expansion of pilot program to include additional ADSM, scaling the pilot program to multiple additional sites, reviewing data collected to refine pharmacogenomic testing, improve efficiency and reproducibility of pilot program, and advanced testing in relevant or simulated operational environments. Potential Funding Availability and Period of Performance: The U.S. Government (USG) currently has available a total of $2.15 million (M) for this effort, for direct and indirect costs. Dependent on the results and deliverables under any resultant award(s), the USG may, non-competitively, award additional dollars and/or allow for additional time for scope increases and/or follow-on efforts with appropriate modification of the award. Cost sharing, including cash and in kind (e.g., personnel or product) contributions are strongly encouraged, have no limit, and are in addition to the Government funding to be provided under the resultant award(s). MTEC expects to make a single award to a qualified Offeror to accomplish the scope of work. If a single proposal is unable to sufficiently address the entire scope of the RPP, several Offerors may be asked to work together in a collaborative manner. The Period of Performance (PoP) is not to exceed 36 months. Acquisition Approach: Enhanced white papers will be required in response to this RPP thus reflecting a single stage acquisition approach. MTEC membership is required for the submission of an enhanced white paper. Proposers Conference: MTEC intends to host a Proposers Conference that will be conducted via virtual webinar on Monday, June 2, 2025 at 12:00 PM Eastern Time. The intent of the Proposers Conference is to provide an administrative overview of this RPP process to award, present the Technical Requirements outlined in Section 3 of this RPP, and answer questions from potential Offerors. To register for this conference, please use the following link: https://ati.zoomgov.com/webinar/register/WN_SZXJ8HqiRGiRPOVnHy2jlw. MTEC Member Teaming: While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to submission) if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government. If you would like teaming assistance, please reach out to the points of contact listed in Section 6 of this RPP. In addition, please connect with the MTEC M-Corps, a network of subject matter experts and service providers, that are available to help MTEC members address the business, technical, and regulatory challenges associated with medical product development. Please visit https://www.mtec-sc.org/ for details on current partners. MTEC: The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, - nontraditional defense contractors, academic research institutions and not-for-profit organizations. Point of Contact: For inquiries, please direct your correspondence to the following contacts: Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Manager, Ms. Taylor Hummell, contact@example.gov Technical and membership questions should be directed to the MTEC Chief Science Officer, Dr. Lauren Palestrini, contact@example.gov All other questions should be directed to the MTEC Program Manager, Mr. Evan Kellinger, contact@example.gov To view the full-length version of this RPP, visit www.mtec-sc.org/solicitations/.